RA-PRO PRAGMATIC TRIAL

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Dec 29, 2020

Keywords

ClinConnect Summary

The RA-PRO Pragmatic Trial is a study designed to help doctors understand the best treatment options for people with rheumatoid arthritis (RA) who are not responding well to their current treatment with a type of medication called TNF inhibitors (TNFi). The trial will compare switching to a different group of medications known as non-TNF biologics (like rituximab or tocilizumab) or targeted synthetic DMARDs (like tofacitinib or baricitinib) to see which approach works better in improving patients' symptoms and overall quality of life.

To participate in the trial, you need to be between 65 and 74 years old and have active RA that is causing significant difficulty in daily life, even after using a TNFi for at least three months. If you're currently taking certain medications for your RA and your insurance allows access to the drugs being tested, you may qualify. Participants will continue to receive standard care while being closely monitored throughout the study. This trial is important because it aims to provide better evidence on how to effectively treat patients with RA who are struggling to find relief from their symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with active, disabling RA (CDAI ≥10 and HAQ ≥0.5) despite the use/experience of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug ;
• • 2. If receiving glucocorticoids (≤10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥2 weeks prior to randomization; and
• • 3. Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies, TNFi-biologic vs. tsDMARD.
• • Participants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan.
• Exclusion Criteria:
• • 1. Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic
• • 2. Prior treatment with targeted synthetic DMARD
• • 3. Concomitant use of leflunomide, sulfasalazine, cyclosporine, or azathioprine within 2-months before randomization;
• • 4. History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD;
• • 5. Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry;
• • 6. Live vaccine within 90 days of study entry;
• • 7. Acute or chronic infections with parenteral antibiotics or hospitalization (including tuberculosis, bacterial sepsis; invasive fungal infections (such as histoplasmosis)) within 1 month or oral antibiotics within 2 weeks of study entry;
• • 8. History of HIV or any opportunistic infection;
• • 9. New York Heart Association Class III or IV heart failure;
• • 10. Latent TB for which anti-tubercular treatment has not been started;
• • 11. Untreated Hepatitis B or C infection;
• • 12. History of deep venous thrombosis or pulmonary embolism; or
• • 13. Pregnant or nursing women; or
• • 14. History of herpes zoster or shingles in the previous 12 months and not subsequently vaccinated with herpes zoster vaccine.